Oral Mucosal Disorder
Conditions
Brief summary
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.
Detailed description
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS). Determine the subjects' acceptance of sloughing and/or other side effects
Interventions
DRUGNo SLS toothpaste
Toothpaste no Sodium Lauryl Sulfate
DRUGMedium SLS toothpaste
Less than or equal to X ppm Sodium Lauryl Sulfate
DRUGHigh SLS toothpaste
More than or equal to X ppm Sodium Lauryl Sulfate
DEVICEAnti-plaque
Rinse prevents bacterial adherence to teeth
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors did not know what toothpaste subjects used.
Intervention model description
The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to understand and willing to sign the informed consent; 2. Willing to agree to maintain confidentiality of the study and study materials; 3. 3M employee aged 18 years and older; 4. Willing to return to the study facility for scheduled study visits and recalls; 5. Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum); 6. Agree to the study instruction and schedule
Exclusion criteria
7. A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation; 8. Have a dental appointment scheduled during study duration for professional cleaning; 9. Is pregnant, nursing, or planning to become pregnant within the study duration; 10. History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants); 11. History of using a prescription antimicrobial mouth rinse during the past 3 months; 12. Currently taking medications which may alter gingival appearance/bleeding; 13. Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health; 14. Participation in any other clinical study within the last 30 days; 15. Resides in the same household with a subject already enrolled in the study; 16. Known history of sensitivity to oral hygiene products; 17. Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes); 18. History of diabetes; 19. Have removable partial/full dentures; 20. Have orthodontic appliances; 21. Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study; 22. Have known sloughing within the last 3 weeks; 23. Have dry mouth; 24. Have widespread caries or chronic neglect; 25. Have gross pathological changes of oral soft tissues; 26. Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss); 27. Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) | End of treatment (3 weeks) | Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | Mid-Treatment (10 days) | Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right) |
| The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | End of Treatment (3 weeks) | Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Reporting Their Acceptance Levels of Side Effects | End of Treatment (3 weeks) | Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comparator: No SLS Toothpaste 3M Oral Rinse in combination with no SLS toothpaste (A)
No SLS toothpaste: Toothpaste no Sodium Lauryl Phosphate
Anti-plaque: Rinse prevents bacterial adherence to teeth | 18 |
| Comparator: Medium SLS Toothpaste 3M Oral Rinse in combination with medium SLS toothpaste (B)
Medium SLS toothpaste: Less than or equal to X ppm Sodium Lauryl Phosphate
Anti-plaque: Rinse prevents bacterial adherence to teeth | 18 |
| Comparator: High SLS Toothpaste 3M Oral Rinse in combination with high SLS toothpaste (C)
High SLS toothpaste: More than or equal to X ppm Sodium Lauryl Phosphate
Anti-plaque: Rinse prevents bacterial adherence to teeth | 17 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Needed crown & cleaning | 0 | 0 | 1 |
| Overall Study | study was terminated | 18 | 18 | 16 |
Baseline characteristics
| Characteristic | Comparator: No SLS Toothpaste | Comparator: Medium SLS Toothpaste | Comparator: High SLS Toothpaste | Total |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 10.3 | 39.7 years STANDARD_DEVIATION 12.09 | 38.5 years STANDARD_DEVIATION 11.82 | 40.5 years STANDARD_DEVIATION 11.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 18 Participants | 16 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with Oral Tissue Sloughing at Baseline | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 17 Participants | 17 Participants | 52 Participants |
| Region of Enrollment United States | 18 Participants | 18 Participants | 17 Participants | 53 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 9 Participants | 31 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 15 / 18 | 15 / 18 | 16 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 17 |
Outcome results
Primary
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Time frame: End of treatment (3 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comparator: No SLS Toothpaste | Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) | 15 Participants |
| Comparator: Medium SLS Toothpaste | Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) | 14 Participants |
| Comparator: High SLS Toothpaste | Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) | 13 Participants |
p-value: 0.916Fisher Exact
Secondary
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time frame: Mid-Treatment (10 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.0, 1.5] | 0 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.5, 1.0] | 1 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | 0 no sloughing | 8 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.0, 0.5] | 9 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.5, 2.0] | 0 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.5, 1.0] | 3 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | 0 no sloughing | 6 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.0, 0.5] | 8 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.0, 1.5] | 0 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.5, 2.0] | 1 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.5, 2.0] | 0 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (1.0, 1.5] | 1 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | 0 no sloughing | 7 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.5, 1.0] | 2 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores | (0.0, 0.5] | 6 Participants |
Secondary
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas. The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue. (upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Time frame: End of Treatment (3 weeks)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | 0 No sloughing | 6 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.0, 0.5] | 9 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.5, 1.0] | 3 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (1.0, 1.5] | 0 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (1.0, 1.5] | 1 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | 0 No sloughing | 9 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.5, 1.0] | 2 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.0, 0.5] | 6 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (1.0, 1.5] | 1 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.0, 0.5] | 6 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | (0.5, 1.0] | 2 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores. | 0 No sloughing | 7 Participants |
Other Pre-specified
The Number of Participants Reporting Their Acceptance Levels of Side Effects
Subjects were questioned regarding how acceptable were your side effects. Using the following responses of: Completely unacceptable, somewhat unacceptable, somewhat acceptable, completely acceptable, did not experience side effects
Time frame: End of Treatment (3 weeks)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comparator: No SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely acceptable | 1 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat acceptable | 1 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely unacceptable | 2 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat unacceptable | 2 Participants |
| Comparator: No SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Did not experience side effects | 12 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat acceptable | 4 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely unacceptable | 1 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat unacceptable | 0 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely acceptable | 4 Participants |
| Comparator: Medium SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Did not experience side effects | 9 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Did not experience side effects | 7 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely acceptable | 3 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Completely unacceptable | 2 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat acceptable | 4 Participants |
| Comparator: High SLS Toothpaste | The Number of Participants Reporting Their Acceptance Levels of Side Effects | Somewhat unacceptable | 1 Participants |